Lord Hunt of Kings Heath: I bear the scars of the debates that we have had on this matter. Although the noble Baroness is right to testify to the work of the PIAG, is she aware of deep concern among many people involved in research in this country that the PIAG process has resulted in a very bureaucratic

20 Oct 2003 : Column 1334

structure for getting approval? Is the noble Baroness concerned that we are not defining the public interest with the right balance? If this country becomes a difficult place in which to undertake research, we shall defeat the whole object of what we are trying to do.

Baroness Cumberlege: As I understand it, CHAI is interested not in research but in audit. When the Patient Information Advisory Group was set up a number of noble Lords took great interest in determining how it would work and were very impressed with the group's rigour. That ensured that the public interest and the private personal interest were maintained. From time to time during the course of this Bill the Minister has been generous in agreeing to reconsider certain issues. The matter that we are discussing is of huge national importance. It needs further consideration. Will the Minister consider the points made tonight and revisit some of the very important debates that we had during the passage of the Health and Social Care Bill in 2001?

Lord Warner: Members of the Committee have made extremely important points on a major issue of public policy. I certainly do not want to give any impression that anything in the Bill is an assault on patient confidentiality, which was the term used. I would like to spend a little time reassuring the Committee that we believe that the information about individual patients is rarely needed in considering the general financial or clinical performance of organisations. Therefore, although it will be for CHAI to determine what information is relevant to its inspections, it is our clear expectationSir Ian Kennedy has confirmed itthat CHAI should use anonymised or aggregated data wherever that is a practical option and will serve the purpose.

CHAI will, of course, be subject to the Data Protection Act 1998, as is currently the case for the Commission for Health Improvement, the National Care Standards Commission and the Audit Commission. With regard to the duty to inform patients that their records may be subject to inspection, it is part of the fair processing requirements of the Data Protection Act that organisations must make reasonable efforts to inform individuals about how their information is to be used. Those are quite powerful protections for individual patients.

I shall deal with Amendments Nos. 358ZB and 358ZC. It would be a significant fetter on CSCI's independence if it needed to ask the Secretary of State's permission every time it wished to access confidential information. That would also add a delay in accessing any such information, so it would serve to prevent the inspectorate acting quickly to access personal information where that was necessary to protect vulnerable individuals.

We do not propose that CSCI should need to access personal data on a regular basis, and the inspectorate will do so only where it is necessary or expedient. In seeking to ensure the protection of vulnerable adults and children, CSCI may from time to time need to access original data, to ensure that they have not been

20 Oct 2003 : Column 1335

altered or tampered with in any way. That is vital in relation to child protection work and the protection of vulnerable adults. From my experience of running a social services department, time can be critical in many such areas.

Members of the Committee are taking the opportunity to ask why the NHS, CHAI and CSCI cannot take steps to ensure that consent procedures are improved or to anonymise records more effectively. Evidence from CHI suggests that seeking consent causes delays and is unlikely to ensure anything like a return of 100 per cent. There are good reasons for that. Some people may consent, some may refuse and some may not reply. The process has to be managed by individual trusts and can cause significant delays on important issues.

Anonymising records is also a time-consuming and complex task requiring careful quality assurance to ensure anonymity. When undertaken on a large scale, it is subject to human error, and in some cases makes demands on hard-pressed clinicians' time. Some issues around anonymity and seeking consent have their own difficulties. I am not arguing the case for not trying to pursue those routes, but trying to set the record straight that they are not always easy solutions when some cases require a timely and speedy intervention.

I sympathise with the concerns of Members of the Committee, but a number of them have said that there have been discussions between the chairmen of CHAI and the GMC. It is worth drawing on some of the evidence of those discussions available to me about the circumstancesseveral Members of the Committee asked about themin which the chairman of CHAI envisages the need for having access to data that relate to individual identifiable patients. One example is issues of child protection when there is a need to follow cases across the boundaries between health and social care serviceswe all know, from some very sad cases that have gone wrong, that some of the boundary issues are pretty criticaland which might involve concerns about parents.

Another area is investigations of serious failures of services, not least in respect of services for particularly vulnerable groups who might not be able to consentfor example, elderly people with severe mental illness, or people with learning disabilities. On audit of economy efficiency and effectiveness in relation to the management of waiting lists, we may need access to the records, as on implementation of NICE guidance. Those are examples from information given to me by the chairman of the Commission for Healthcare Audit and Inspection. I have used them to try to answer some of the questions raised by Members of the Committee.

It is also worth bearing in mind that Clause 134 makes it clear that an employee of CHAI would be committing a criminal offence if he knowingly or recklessly disclosed patient-identifiable information given in confidence. We have made such a provision to support our emphasis on the importance of patient confidentiality, and as a means to reassure the publicand healthcare professionalsthat CHAI, in its privileged role, will not abuse its position.

20 Oct 2003 : Column 1336

We should let the work taking place between CHAI and the GMC unfold a little further. They are working towards a code of practice that will strike the right balance. We need to give them more time, and I am sure that they will come forward with a document that will meet many of the concerns expressed.

Several Members of the Committee have raised the subject of the Patient Information Advisory Group. Unlike my noble friend Lord Hunt, I do not bear the scars of the discussions on that; no doubt in a few years' time I shall be talking about scars in relation to this Bill. We are pretty confidentthe chairman of CHAI will read Hansard on the subjectthat CHAI will consult the Patient Information Advisory Group, among others, as a code of practice evolves from the work that CHAI is doing with the GMC. CHAI will be aware of the work done by noble Lords in this House on an earlier Bill. I assure the noble Baroness, Lady Cumberlege, that I will carefully read the earlier debates to inform myself better before Report.

In those circumstances, I hope that the Committee is reassured that the Government take the issue very seriously. A difficult balance is to be struck, as said by the noble Lord, Lord Clement-Jones, but the right way to proceed is to let the work on the code of practice between CHAI and the GMC continue, rather than pursuing the route of an amendment to the legislation at this stage.

7.15 p.m.

Lord Clement-Jones: The noble Lord has been very helpful in terms of giving some examples of circumstances in which personal information that has not been anonymised might be needed. I think that he gave four examples. He also talked further about the code of practice. However, what is the timing of that code? Even for those of us who recognise that a balance needs to be struck, that there are circumstances in which consent is not possible, and that the Patient Information Advisory Group is the right mechanism, a bit of expedition would not go amiss. It would enable us on Report to at least have something rather more concrete.

Lord Warner: I am very happy to take soundings from the two titans, as the noble Lord called them earlier. Given all the discussions that we have had about the independence of CHAI, I am sure that he would not want me to be terribly heavy-handed, or I should be accused of the Secretary of State interfering unnecessarily. I understand his concerns, will make inquiries, and will write to all Members of the Committee when I have some better information on the time scales involved.

Baroness Cumberlege: I thank the Minister for his reply. It was disappointing for me in that I had hoped that the noble Lord would go further. I accept, as do all noble Lords, that confidentiality is not an absolute. There will be circumstances, which the Minister has illustrated, where there is a strong public interest and disclosure is necessary. The matter that worries me is that we do not seem to have a good process for dealing

20 Oct 2003 : Column 1337

with that situation. The Minister mentioned the code. I am not sure exactly how we have an influence on that code.

We have described the two titans. Where is the referee? How can we, noble Lords who are very concerned about this, influence that code? I am frightened that the matter will be decided between the organisations involved. We may have a different perspective. Indeed, we did last time. If the mechanism that I have suggested is not the right one, I hope that the Minister will come back with not just a codethat is too loosebut with something that we can be certain is independent and, yes, quick, fast and resolute. Simply to say that it will be inconvenient and irksome to have a delay is not good enough. We can surely devise a mechanism that fits the needs here, but is not as loose as a code over which we have no control.